Panel Urges Child Antidepressants Warning

Panel Urges Child Antidepressants Warning

By LAURAN NEERGAARD The Associated Press

WASHINGTON (AP) - All drugs used to treat depressed children should carry a ``black box'' warning of the antidepressants' link to increased suicidal thoughts and actions, says a panel of federal advisers.

The warning, among the strongest in the Food and Drug Administration's arsenal, should reach doctors no matter how they get drug information and would extend to drug advertising directed at patients.

That's the majority opinion of federal advisers, who heard testimony Monday about antidepressants' powers and perils from doctors, researchers and relatives of patients who killed themselves after taking such medication. The panel spent the bulk of Tuesday deliberating before issuing its recommendation.

The black box option is more strident than the bold-letter warnings the same federal advisers suggested be added to antidepressant labels this March. Antidepressant prescription rates to children were unchanged by the earlier warning.

Unlike the earlier red flag, advisers said this new warning should make clear that antidepressants have been linked to two to three more children per 100 having heightened suicidal thoughts and behaviors.

The FDA will spend the next few weeks reviewing transcripts of the committee's comments before it decides which actions to take. The FDA isn't required to follow the recommendations of its advisory committees, but usually does so.

A suggestion that the agency create an antidepressant guide written in laymen's terms appears to be a slam dunk, since three dozen drugs already include them and the FDA advisory panel unanimously endorsed that concept.

The black box warning, endorsed by some families, garnered 15 supporters and eight dissenters among FDA advisers. Two voting members of the panel left the marathon meeting before Tuesday's crucial vote.

``When the decision is divided, it's less of a sure thing,'' Dr. Robert Temple, director of the FDA's Office of Drug Evaluation, told reporters later.

Wyeth Pharmaceuticals, which manufactures the antidepressant Effexor, will note that split decision when it discusses the best warning option with FDA officials, said Dr. Joseph Camarado, senior vice president of medical affairs.

A dozen psychiatrists who testified during the two-day hearing will probably weigh in with more details of antidepressants' benefits for children, said Dr. David Fassler, trustee at large for the American Psychiatric Association.

``It's important to note it was a split vote. I think that's consistent with the fact the data is not entirely consistent or clear,'' Fassler said. ``I don't think the discussion is over.''

On Monday, Fassler testified that 3 percent to 5 percent of children are depressed and that more than 500,000 depressed children attempt suicide each year.

Many FDA advisers said they were conflicted: Grieving families clearly wanted heightened warning labels. Yet, mental health professionals fretted about the chilling effect of black box warnings, a note that comes at the top of the drug's label, whether it arrives electronically or by paper.

Dr. Matthew Rudorfer, a mood disorder specialist at the National Institute of Mental Health, voted against the black box warning. The 2 percent to 3 percent increased risk of suicidal thoughts that alarmed the panel was overshadowed by the 15 percent risk of suicides by children with untreated depression. ``I fear the black box would impede access to treatment,'' Rudorfer said.

FDA advisory committee chairman Dr. Wayne Goodman, psychiatry chairman at the University of Florida, acknowledged complications for prescribing physicians while still voting for the proposal. ``I anticipate there will be alarm from parents and the child,'' Goodman said. ``I think that's worth that complication, because it will raise the threshold'' for prescribing the drugs to children.

The black-box warning should be joined by data showing which antidepressants work for depressed children, FDA advisers suggested. The recommendation, if endorsed by the drug agency, would mean that Prozac, shown in three studies to effectively treat depressed youth, would carry that notice. Paxil's shortcomings in treating 700 depressed children in clinical trials, meanwhile, could become more transparent.

The panel stopped short of asking for an outright ban on antidepressants for children.

A black-box warning would have made a ``huge difference'' in alerting patients to risks, said Kathleen Bodnar, whose 21-year-old daughter killed herself last March while taking Celexa. Liz Torlakson switched to Celexa from a liver-damaging competitor 16 months earlier, when ``she demanded that her doctor give her something safe,'' Bodnar said.

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Panels mull antidepressant data FDA addresses suicidal thoughts in kids.

Associated Press September 14, 2004

WASHINGTON (AP) - Federal health advisers considering more stringent warning labels for antidepressants linked to suicidal thoughts among children told the Food and Drug Administration today that they might consider more than just a label change.

One member of the panel asked the drug agency whether it could require that those prescribing the drugs undergo training to better recognize warning signs.

Joan Chesney, chairwoman of the FDA pediatric advisory committee, said her daughter has taken antidepressants. "I was appalled," Chesney said, upon learning that psychiatrists were signing prescriptions that had been written by social workers, pharmacists and emergency room doctors.

"The people who are prescribing this on the whole are not psychiatrists," she said.

Data presented to the FDA show that 65 percent of antidepressants taken by children are prescribed by psychiatrists. Independent experts and FDA scientists have said there is a definite link between antidepressants and the worsening suicidal fixations of children taking the drugs.

The latest analysis forms the heart of data that FDA advisers were considering during the second day of hearings on antidepressants. Even Prozac - shown in earlier studies to be the most benign antidepressant for youths - increases the odds of suicidal thoughts and actions.

On average, antidepressants taken by kids will cause an extra 2 percent to 3 percent to have increased suicidal thoughts, the independent experts, working with Columbia University, found.

Relative risks of suicidal behavior were highest among youths taking Luvox, Effexor and Paxil and lower among youths taking Celexa, Zoloft and Prozac.

Two FDA advisory committees, meeting jointly, spent yesterday listening to summaries of the current science. And for hours, parents described the heartbreak of suicides they blamed on antidepressants.

Tom Woodward, whose 17-year-old daughter, Julie, hanged herself while she was on Zoloft, said, "Drug companies have purposely deceived the public about the safety and efficacy of their drugs."

During congressional hearings last week, critics said the FDA and drug companies have provided scant details of pediatric clinical trials for antidepressants. GlaxoSmithKline, the maker of Paxil, has been hit with a lawsuit accusing it of suppressing studies indicating the drug might increase suicidal tendencies in kids.

But drug company representatives testified yesterday that the industry_s studies had limitations. The studies weren_t designed to test whether they made patients suicidal and included no direct drug-to-drug comparisons.

Under legislation passed in 1997, pharmaceutical companies had agreed to do more clinical trials involving children in exchange for six months of exclusive marketing of their drugs. That legislation boosted drug company profits.

Still, Wayne Goodman, one FDA advisory committee chairman, wondered whether that law inadvertently spawned speedy clinical trials designed, from day one, to guarantee a positive finding for the drug.

Two FDA advisory panels are considering whether agency action - including stronger warning labels - is needed on nine antidepressants linked to heightened suicidal tendencies among children.

Robert Temple, director of the FDA's office of drug evaluation, said the panel could decide the benefits derived from drugs such as Prozac are worth the increased risk. Labels could warn doctors and families to watch most closely during the most treacherous time: when children first begin therapy.

Woodward, 47, was one of more than 70 speakers enveloping federal health advisers yesterday in an outpouring of emotion, tears and anger. He said his daughter had been taking Zoloft for just seven days when she killed herself.

Other witnesses, such as Cynthia Wainscott, chairwoman of the National Mental Health Association, urged the FDA not to take away drugs credited with reducing suicides among depressed youths.

She showed panel members a photograph of her granddaughter Jessi, who she said began suffering from depression at age 11. Now 15 and on medication, Jessi has returned to her normal self, her grandmother said.

Untreated depression is a serious illness that threatens children_s lives, said Laurence Greenhill, speaking on behalf of the American Academy of Child and Adolescent Psychiatry. He said he found it reassuring that analysis did not find a single completed suicide among 4,440 depressed youths in drug company-sponsored clinical trials.

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U.S. FDA Resisting Antidepressant Probe -- Lawmaker

Reuters September 9, 2004

A top Republican lawmaker on Thursday charged the U.S. Food and Drug Administration with hindering a congressional investigation into whether the agency suppressed a possible link between antidepressant use and suicidal behavior in youth.

Rep. Joe Barton, chairman of the U.S. House Energy and Commerce Committee, said the FDA has been uncooperative during the committee's investigation, which began as a general probe into the risks of the mood-enhancing medicines in children and teens.

"Unfortunately, over the last several months, the committee has been met mostly with stonewalling, slow-rolling and plain incompetency from the FDA," said Barton, of Texas.

The committee asked the agency to supply lawmakers with all related documents, but an FDA employee decided to limit the number of documents it sent, Barton charged.

If necessary, "we will send committee staff to the FDA with the (U.S.) Capitol Police ... and we will go through the files ourselves," he said.

FDA spokesman Jason Brodsky said the agency has turned over thousands of pages of documents as part of the investigation. "We have provided all the information requested in the chairman's letter, and we will continue to cooperate and provide any and all information requested," Brodsky said.

He added that committee staffers had declined FDA offers to come to the FDA offices to review the documents with agency librarians.

Seven months ago, the committee began probing whether widely used drugs would increase the risk of children and teenagers committing suicide, prompted by the agency review of the drugs.

One FDA reviewer, Andrew Mosholder, concluded there was a link, but other agency officials disagreed and decided Mosholder should not present his views at an advisory committee meeting held earlier this year.

The FDA has not reached a final decision about any link, but last month announced it would update antidepressant labels to include information from various studies.

It also called for a separate analysis from Columbia University that Mosholder has said echoes many of his concerns.

A panel of outside experts convened by the FDA meets next week to discuss the new analysis and other information.

This 'Mental Health E-News' posting is a service of the New York Ass'n of Psychiatric Rehabilitation Services, a statewide coalition of people who use and/or provide community mental health services dedicated to improving services and social conditions for people with psychiatric disabilities by promoting their recovery, rehabilitation and rights. To join our list, please click on the E-News Subscription button.

Last Updated on 09/15/04 webmaster@namiscc.org

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